Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction
NCT ID: NCT04050982
Last Updated: 2023-09-22
Study Results
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View full resultsBasic Information
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TERMINATED
NA
11 participants
INTERVENTIONAL
2019-10-01
2023-01-26
Brief Summary
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The prospective, RCT portion of this study compare cardiovascular risk factors (CVRF), AF knowledge, AF Symptom Severity and Burden, and QOL between and within the wait list group and the AF CARE group at baseline, 3, 6, and 12 months.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Pilot Testing
Patients interface with the digital application, providing feedback on usability and satisfaction.
AF CARE
Patients will receive personalized messages twice weekly that will include behavior recommendations for CVRF reduction and AF education based on the initially entered psychographic profile and data entered.
AF CARE plus Usual Care
Patients will interface with the digital application.
AF CARE
Patients will receive personalized messages twice weekly that will include behavior recommendations for CVRF reduction and AF education based on the initially entered psychographic profile and data entered.
Usual Care
Participants will be given recommendations for CVRF reduction based on their initial American Heart Association Life Simple 7 (LS7) assessment and will be provided educational materials and be wait listed for digital app 3 months later
Usual Care then AF Care
After a 6 month period of usual care only, patients will interface with the digital application.
Usual Care
Participants will be given recommendations for CVRF reduction based on their initial American Heart Association Life Simple 7 (LS7) assessment and will be provided educational materials and be wait listed for digital app 3 months later
Interventions
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AF CARE
Patients will receive personalized messages twice weekly that will include behavior recommendations for CVRF reduction and AF education based on the initially entered psychographic profile and data entered.
Usual Care
Participants will be given recommendations for CVRF reduction based on their initial American Heart Association Life Simple 7 (LS7) assessment and will be provided educational materials and be wait listed for digital app 3 months later
Eligibility Criteria
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Inclusion Criteria
2. Access and willingness to engage in digital technology
3. Has a valid email address and a cell phone number
4. Able to ambulate
5. Able to speak/read English
Exclusion Criteria
2. MI or cardiac surgery in prior 3 months
3. Severe renal/hepatic disease
4. Active malignancy
5. Current/recent (within 6 months) enrollment in weight loss program
18 Years
ALL
No
Sponsors
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American Heart Association
OTHER
PatientBond
INDUSTRY
Stanford University
OTHER
Responsible Party
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Paul Wang
Director, Stanford Electrophysiology and Arrhythmia Service
Principal Investigators
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Linda Ottoboni, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinician and research scientist
Locations
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Stanford Health Care
Stanford, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB# 48183
Identifier Type: -
Identifier Source: org_study_id
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